Average Ratings 0 Ratings
Average Ratings 0 Ratings
Description
Streamline the processes involved in batch records, cleaning, environmental oversight, and inventory control. Enhance the production of advanced therapies using software tailored for Good Manufacturing Practice (GMP). This tool serves as an effective means to unify your workforce towards achieving ‘right-first-time manufacturing’. Eliminate the chaos of scattered paperwork by utilizing a single software solution that facilitates data collection, review and approval workflows, comprehensive reporting, and insightful analytics. Guarantee that your team adheres to the proper protocols promptly with engaging work instructions that guide them through each step. Enjoy peace of mind knowing that the software complies with 21 CFR part 11 and EU Vol 4 annex 11. Simplify the logging of information with features like barcode scanning, integrated data integrity measures, and automatic calculations. The system also includes built-in mechanisms for identifying out-of-spec conditions and ensuring thorough review and approval. Stay informed about the status of your samples throughout the testing phases, while efficiently organizing sample plans and automating trend analysis. Additionally, manage tasks related to maintaining cleanroom standards and monitor various stages of the production process to ensure optimal results. This comprehensive approach not only enhances efficiency but also fosters an environment of accountability and precision in manufacturing.
Description
SimplerQMS offers a cloud-based Quality Management Software, specifically designed for the Life Science industry.
SimplerQMS helps ensure compliance with various regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, GxP, cGMP, GAMP 5, GDPR, EU IVDR & EU MDR, ISO 13485:2016, 21 CFR Part 820, and ICH Q10, among others. The system is fully validated according to GAMP5.
The system offers a range of Life Science QMS modules such as Document Control, Change Control, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, Quality KPIs and more.
SimplerQMS integrates with Microsoft Office and allows users to work with documents in applications such as Word, PowerPoint, and Excel.
Overall, SimplerQMS delivers efficient, paperless workflows that align with the compliance requirements of the Life Science industry.
API Access
Has API
API Access
Has API
Integrations
Microsoft 365
Microsoft Entra ID
Pricing Details
No price information available.
Free Trial
Free Version
Pricing Details
$13,750/year
Free Trial
Free Version
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Vendor Details
Company Name
MyCellHub
Founded
2019
Country
Belgium
Website
www.mycellhub.com
Vendor Details
Company Name
SimplerQMS
Founded
2017
Country
Denmark
Website
www.simplerqms.com
Product Features
Manufacturing Execution
Document Management
Forecasting
Quality Control
Quote Management
Resource Management
Supplier Management
Supply Chain Management
Traceability
Product Features
Audit
Alerts / Notifications
Audit Planning
Compliance Management
Dashboard
Exceptions Management
Forms Management
Issue Management
Mobile Access
Multi-Year Planning
Risk Assessment
Workflow Management
CAPA
Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management
Compliance
Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation
Document Control
Archiving & Retention
Automated Routing
Change Management
Compliance Management
Electronic Signature
Escalation Management
Periodic Review
Version Control
Quality Management
Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management